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China: Vaccine Law Passed

(Aug. 27, 2019) On June 29, 2019, the National People’s Congress Standing Committee of the People’s Republic of China (PRC or China) adopted the PRC Law on Vaccine Administration (Vaccine Law). The official Xinhua news agency statesthat the Law provides for the “strictest” vaccine management with tough penalties in order to ensure the country’s vaccine safety.

Before the passage of this 100-article Law, provisions governing vaccines were contained in the PRC Drug Administration Law, PRC Law on the Prevention and Treatment of Infectious Diseases, and a few relevant administrative regulations and rules.

The new Law provides for regulatory requirements for researching, producing, distributing, and using vaccines. Such requirements, according to one legal commentator, are much more stringent than those for other drugs (art. 2). It also contains a chapter specifying penalties for violating the Vaccine Law, which are also stricter than those for violating other drug laws (ch. 10). According to the Law, if any violation of this Law constitutes a crime, a “heavier punishment” within the range of punishments provided by the Criminal Law on the relevant crimes is to be imposed (art. 79).

The Law mandates the launching of a national vaccine electronic tracking platform that integrates tracking information throughout the whole process of vaccine production, distribution, and use to ensure all vaccine products can be tracked and verified (art. 10).

According to the Law, China is to implement a state immunization program, and residents living within the territory of China are legally obligated to be vaccinated with immunization program vaccines, which are provided by the government free of charge. Local governments and parents or other guardians of children must ensure that children be vaccinated with the immunization program vaccines (art. 6).

The Law establishes a compensation system for abnormal reactions to vaccination. A recipient of an immunization program vaccine who dies or suffers significant disability or organ and tissue damage is to be paid from the vaccination funds of the provincial level government if the damage falls within the scope of abnormal reactions associated with a vaccine or cannot be prevented (art. 56).

The Law will take effect on December 1, 2019 (art. 100).

Law
Vaccine administration law of the people’s Republic of China
(Adopted by the 11th meeting of the Standing Committee of the 13th National People’s Congress on June 29, 2019）
Release time： 2019-07-03 13: 58 source: China people’s Congress
Contents

　　Chapter I general provisions

　　Chapter II vaccine development and registration

　　Chapter III vaccine production and issuance

　　Chapter IV vaccine circulation

　　Chapter V vaccination

　　Chapter VI monitoring and handling of abnormal reactions

　　Chapter VII post-market Administration of vaccines

　　Chapter VIII safeguards

　　Chapter IX supervision and management

　　Chapter X legal liability

　　Chapter XI supplementary provisions

Chapter I general provisions

　　Article 1 this law is enacted in order to strengthen vaccine management, ensure vaccine quality and supply, standardize vaccination, promote the development of the vaccine industry, protect public health and maintain public health safety.

　　Article 2 this law shall apply to vaccine development, production, circulation and inoculation, as well as to supervision and administration activities within the territory of the people’s Republic of China.Where there are no provisions in this law, the provisions of laws and administrative regulations such as the Drug Administration Law of the people’s Republic of China and the prevention and control of infectious diseases law of the people’s Republic of China shall apply.

　　The term “vaccine” as used in this law refers to preventive biological products used for human immunization for the purpose of preventing and controlling the occurrence and prevalence of diseases, including immunization planning vaccines and non-immunization planning vaccines.

　　Article 3 the state shall implement the strictest management system for vaccines,and adhere to safety first,Risk Management, full control, scientific supervision and social co-governance.

　　Article 4 the state adheres to the strategic and public welfare nature of vaccine products.

　　The state supports basic and applied research on vaccines,promotes vaccine development and innovation, and integrates vaccine development, production and stockpiling for the prevention and control of major diseases into national strategies.

　　The state has formulated plans and industrial policies for the development of the vaccine industry, supported the development and structural optimization of the vaccine industry, encouraged large-scale and intensive vaccine production, and continuously improved the level of vaccine production technology and quality.

　　Article 5 the holder of a vaccine marketing license shall strengthen the quality management of the whole life cycle of the vaccine and be responsible for the safety, effectiveness and quality control of the vaccine.

　　Units and individuals engaged in vaccine development, production, circulation and vaccination activities shall abide by laws, regulations, rules, standards and norms, ensure that the information in the whole process is true, accurate, complete and traceable, assume responsibility in accordance with law and accept social supervision.

　　Article 6 the state shall implement an immunization planning system.

　　Residents residing within the territory of China shall enjoy the right to vaccinate against immunization programmes in accordance with the law and fulfill the obligation to vaccinate against immunization programmes.The government provides immunization programme vaccines to the population free of charge.

　　The people’s governments at or above the county level and their relevant departments shall ensure that children of school age are vaccinated against immunization programmes.Guardians shall ensure that children of school age are vaccinated on time in accordance with the law.

　　Article 7 people’s governments at or above the county level shall incorporate vaccine safety work and vaccination work into their national economic and social development plans at the corresponding level, strengthen capacity-building for vaccine supervision and management, and establish and improve the mechanism for vaccine supervision and management.

　　Local people’s governments at or above the county level are responsible for the supervision and administration of vaccines in their respective administrative regions, and unify the leadership, organization and coordination of the supervision and administration of vaccines in their respective administrative regions.

　　Article 8 the pharmaceutical supervision and Administration Department under the state council shall be responsible for the supervision and administration of vaccines throughout the country.The competent Department of Health and health under the state council shall be responsible for the supervision and administration of inoculation prevention throughout the country.Other relevant departments under the state council shall be responsible for the supervision and administration of vaccines within the scope of their respective functions and responsibilities.

　　The pharmaceutical supervision and administration departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government are responsible for the supervision and administration of vaccines in their respective administrative areas.The Departments of the people’s governments at the municipal and county levels divided into districts that bear the responsibilities of drug supervision and administration(hereinafter referred to as the drug supervision and administration departments)are responsible for the supervision and administration of vaccines in their respective administrative areas.The department in charge of Health and health of the local people’s governments at or above the county level shall be responsible for the supervision and administration of vaccination in their respective administrative areas.Other relevant departments of the local people’s governments at or above the county level shall be responsible for the supervision and administration of vaccines within the scope of their respective functions and responsibilities.

　　Article 9 the state council and the people’s governments of provinces, autonomous regions and municipalities directly under the central government shall establish departmental coordination mechanisms to coordinate and coordinate the relevant work of vaccine supervision and administration in an overall manner, regularly analyze the safety situation of vaccines, strengthen vaccine supervision and administration and ensure the supply of vaccines.

　　Article 10 the state implements a system of electronic traceability of vaccines throughout the whole process.

　　The pharmaceutical supervision and Administration Department under the state council, in conjunction with the competent health and health department under the state council, has formulated unified standards and norms for vaccine traceability, established a national collaborative platform for electronic vaccine traceability, and integrated information on the traceability of vaccine production, circulation and the whole process of vaccination so as to achieve vaccine traceability.

　　The holder of the vaccine listing license shall establish an electronic vaccine traceability system, which is connected with the National Vaccine electronic traceability collaborative platform, so as to achieve the traceability and verifiability of the vaccine in the smallest packaging unit in the whole process of production, circulation and vaccination.

　　Disease prevention and control agencies and inoculation units shall truthfully record the circulation of vaccines, inoculation, etc. according to law, and provide retroactive information to the National Electronic vaccine traceability collaborative platform in accordance with regulations.

　　Article 11 in the course of vaccine development, production and testing, a system of biosafety management shall be established and improved, biosafety risks shall be strictly controlled, Biosafety Management of pathogenic microorganisms such as bacteria and strains shall be strengthened, the health of operators and the public shall be protected, and the use of pathogenic microorganisms such as bacteria and strains shall be guaranteed to be lawful and legitimate.

　　Vaccine development, production, testing and other use of bacterial strains and cell lines, should be clear history, biological characteristics, generations, the establishment of detailed files to ensure that the source is legal, clear and traceable;unknown sources, may not be used.

　　Article 12 people’s governments at various levels, their relevant departments, disease prevention and control institutions, inoculation units, holders of vaccine marketing licenses and vaccine trade associations, etc. shall, through the National Children’s vaccination day and other activities, regularly carry out publicity, education and popularization of vaccine safety laws, regulations and knowledge of vaccination prevention.

　　The news media shall carry out public public publicity on vaccine safety laws, regulations and knowledge of vaccination prevention, and supervise public opinion on vaccine violations.Publicity reports on vaccines should be comprehensive, scientific, objective and fair.

　　Article 13 the vaccine industry association shall strengthen industry self-discipline,establish and improve industry norms, promote the construction of industry integrity System, Guide and urge members to carry out production and operation activities in accordance with the law.

Chapter II vaccine development and registration

　　Article 14 the state, on the basis of factors such as the epidemic situation of diseases and the immunization status of populations, shall formulate relevant research and development plans and arrange necessary funds to support the development of new vaccines such as polyvalent polyvalent ones.

　　The state has organized joint research on Vaccine Market License holders, scientific research units and medical and health institutions to develop vaccines that are urgently needed for Disease Prevention and control.

　　Article 15 the state encourages holders of vaccine marketing licenses to increase investment in research and innovation funds, optimize production processes, raise the level of quality control and promote the progress of vaccine technology.

　　Article 16 clinical trials of vaccines shall be approved by the pharmaceutical supervision and Administration Department under the state council in accordance with law.

　　Clinical trials of vaccines shall be carried out or organized by three-level medical institutions or disease prevention and control institutions at or above the provincial level that meet the conditions prescribed by the drug supervision and Administration Department under the state council and the competent Department of Health and health under the state council.

　　The state encourages qualified medical institutions,disease prevention and control institutions, etc. to carry out clinical trials of vaccines in accordance with law.

　　Article 17 applicants for clinical trials of vaccines shall formulate clinical trial plans, establish a system of safety monitoring and evaluation of clinical trials, carefully select subjects, rationally set up subjects groups and age groups, and take effective measures according to the degree of risk to protect the legitimate rights and interests of subjects.

　　Article 18 in carrying out clinical trials of vaccines, the written informed consent of the subject shall be obtained;if the subject is a person without civil capacity, the written informed consent of his or her guardian shall be obtained;if the subject is a person with limited civil capacity, the written informed consent of the subject and his or her guardian shall be obtained.

　　Article 19 vaccines listed in China shall be approved by the pharmaceutical supervision and Administration Department under the state council and obtain a certificate of drug registration;when applying for vaccine registration, truthful, adequate and reliable data, materials and samples shall be provided.

　　The pharmaceutical supervision and Administration Department under the state council shall give priority to review, review and approval of urgently needed vaccines and innovative vaccines for Disease Prevention and control.

　　Article 20 where a vaccine urgently needed in response to a major public health emergency or other vaccine deemed urgently needed by the competent Department of Health and health under the state council has an assessment that the benefit is greater than the risk, the pharmaceutical supervision and Administration Department under the state council may approve an application for registration of the vaccine with conditions.

　　In the event of a particularly major public health emergency or other emergency that seriously threatens public health, the competent Department of Health and health under the state council shall, in accordance with the need for the prevention and control of infectious diseases, make recommendations for the emergency use of vaccines, which may be used urgently within a certain range and within a certain time limit after the approval of the organization and demonstration by the drug supervision and Administration Department under the state council.

　　Article 21 when approving an application for vaccine registration, the pharmaceutical supervision and Administration Department under the state council shall approve the production process, quality control standards, instructions and labels of vaccines.

　　The pharmaceutical supervision and Administration Department under the state council shall promptly publish the contents of the vaccine manual and label on its website.

Chapter III vaccine production and issuance

　　Article 22 the state implements a strict access system for vaccine production.

　　To engage in vaccine production activities, a pharmaceutical production license shall be obtained with the approval of the pharmaceutical supervision and Administration Department of the people’s government at or above the provincial level.

　　Engaged in vaccine production activities, in addition to meeting the “people’s Republic of China Drug Administration Law” to engage in drug production activities, but also shall meet the following conditions：

　　(I)have a moderate scale and sufficient capacity reserves;

　　(2)have systems and facilities and equipment to ensure biosafety;

　　(3)Meet the needs of disease prevention and control.

　　The holder of the vaccine marketing license shall have the vaccine production capacity;where it is necessary to entrust production beyond the vaccine production capacity, it shall be approved by the pharmaceutical supervision and Administration Department under the state council.Those who accept commissioned production shall abide by the provisions of this law and the relevant provisions of the state to ensure the quality of vaccines.

　　Article 23 the legal representative and main person-in-charge of the holder of the vaccine listing license shall have a good credit history, and the personnel in key positions such as the person-in-charge of production management, the person-in-charge of quality management and the person-in-charge of Quality Authority shall have relevant professional background and experience.

　　The holder of the vaccine marketing license shall strengthen the training and assessment of the personnel specified in the preceding paragraph, and promptly report their positions and changes to the pharmaceutical supervision and administration departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government.

　　Article 24 vaccines shall be produced and tested in accordance with the approved production process and quality control standards, and the whole process of production shall comply with the requirements of the quality management standards of pharmaceutical production.

　　The holder of the vaccine marketing license shall, in accordance with the provisions, review and inspect the whole process of vaccine production and vaccine quality.

　　Article 25 the holder of the Vaccine Market License shall establish a complete production quality management system, continue to strengthen the management of deviations, use information technology means to truthfully record all the data formed in the process of production and inspection, to ensure that the whole process of production continues to meet the statutory requirements.

　　Article 26 the state shall implement a system for granting and issuing vaccines.

　　Before each batch of vaccines is sold or imported, it shall be audited and inspected by the approval and issuance agency designated by the drug supervision and Administration Department under the state council in accordance with the relevant technical requirements.If the requirements are met,a certificate of approval shall be issued;if the requirements are not met, a notice of non-approval shall be issued.

　　Vaccines not approved and issued shall not be sold, and shall be destroyed under the supervision of the pharmaceutical supervision and Administration Department of the people’s government of the province, autonomous region or municipality directly under the central government;imported vaccines not approved and issued shall be destroyed under the supervision of the pharmaceutical supervision and Administration Department of the port where they are located or subjected to other treatment according to law.

　　The drug supervision and Administration Department under the state council and the approval and issuance agency shall promptly publish the results of the approval and issuance of listed vaccines for public inquiry.

　　Article 27 an application for vaccine approval and issuance shall, in accordance with the provisions, provide the approval and issuance institution with the batch production and inspection records summary and other materials and samples of the same batch number of products.Imported vaccines shall also provide proof of origin, approval and issuance of certificates;in the country of origin is exempted from approval and issuance of certificates, shall provide exemption and issuance of certificates.

　　Article 28 vaccines that are urgently needed to prevent or control the epidemic of infectious diseases or to respond to emergencies shall be exempted from approval and issuance by the pharmaceutical supervision and Administration Department under the state council.

　　Article 29 the issuance of vaccine batches shall be subject to data review and sampling inspection batch by batch.Vaccine approval and issuance inspection items and inspection frequency shall be dynamically adjusted according to the vaccine quality risk assessment.

　　Where there is doubt about the authenticity of the application materials or samples for vaccine approval and issuance, or there are other circumstances that require further verification, the approval and issuance agency shall verify it, and, if necessary, shall organize on-site verification by means of on-site sampling and inspection.

　　Article 30 where the approval and issuance agency finds that there are major quality risks to the vaccine during the approval and issuance process, it shall promptly report to the drug supervision and Administration Department under the state council and the drug supervision and Administration Department of the people’s governments of provinces, autonomous regions and municipalities directly under the central government.

　　The department receiving the report shall immediately conduct on-site inspection of the holder of the vaccine listing license, notify the approval and issuance agency on the basis of the results of the inspection of the relevant products or all products of the vaccine listing license holder shall not be approved and issued or suspend the approval and issuance, and order the holder of the vaccine listing license to rectify.The holder of the vaccine marketing license shall immediately rectify the situation and promptly report the rectification to the Department ordered to rectify the situation.

　　Article 31 the holder of the vaccine marketing license shall truthfully record the deviations in the production process, the difference in quality, the faults and accidents in the production process and the measures taken, and set out in the documents for the approval and issuance of the corresponding batch of products;where the quality of the vaccine may be affected, the holder of the vaccine marketing license shall immediately take measures and report them to the pharmaceutical supervision and Administration Department of the people’s government of the province, autonomous region or municipality directly under the central government.

Chapter IV vaccine circulation

　　Article 32 the competent Department of Health and health under the state council, together with the financial Department of the state council and other organizations, shall conduct centralized bidding or unified negotiations for vaccines under the State Council to form and announce the winning bid price or the transaction price, and all provinces, autonomous regions and municipalities directly under the central government shall conduct unified procurement.

　　Other immunization planning vaccines and non-immunization planning vaccines other than the national immunization planning vaccines shall be procured by provinces, autonomous regions and municipalities directly under the central government through provincial public resource trading platforms.

　　Article 33 the price of the vaccine shall be set independently and rationally by the holder of the vaccine listing license according to law.The price level, spread rate and profit margin of the vaccine should be maintained at a reasonable margin.

　　Article 34 disease prevention and control institutions at the provincial level shall, in accordance with the national immunization plan and the disease prevention and control needs of their respective administrative regions, formulate plans for the use of vaccines in their respective administrative regions, and report them to the departments that organize the procurement of vaccines in accordance with the relevant provisions of the state, and report them to the departments in charge of Health and health of the people’s governments of provinces, autonomous regions and municipalities directly under the central government for the record.

　　Article 35 the holder of the vaccine marketing license shall supply the vaccine to the disease prevention and control agency in accordance with the provisions of the procurement contract.

　　The CDC shall supply vaccines to inoculating units in accordance with the provisions.

　　Units and individuals other than the disease prevention and control agency shall not supply the vaccine to the inoculation unit, and the inoculation unit shall not receive the vaccine.

　　Article 36 the holder of the vaccine marketing license shall, in accordance with the procurement contract, distribute the vaccine to the agency for Disease Prevention and control or the vaccination unit designated by the agency for Disease Prevention and control.

　　The holder of the vaccine listing license and the disease prevention and control agency shall have the conditions for the cold chain storage and transportation of the vaccine, and may also entrust the vaccine distribution unit that meets the conditions to distribute the vaccine.

　　The agency for Disease Prevention and control may charge storage and transportation costs for the distribution of non-immunized planned vaccines. the specific measures shall be formulated by the financial department under the state council in conjunction with the price Department under the state council, and the fees shall be formulated by the price Department under the people’s government of a province, autonomous region or municipality directly under the central government in conjunction with the financial department.

　　Article 37 disease prevention and control institutions, inoculation units, holders of vaccine marketing licenses and vaccine distribution units shall abide by the regulations on the management of vaccine storage and transportation to ensure the quality of vaccines.

　　Vaccine in the storage, transportation of the whole process should be in the specified temperature environment, cold chain storage, transportation should meet the requirements, and regularly monitor and record the temperature.

　　The regulations for the administration of vaccine storage and transportation shall be jointly formulated by the pharmaceutical supervision and Administration Department under the state council and the department in charge of Health and health under the state council.

　　Article 38 when selling vaccines, the holder of the vaccine marketing license shall provide a copy of the approval and issuance certificate affixed to his seal or an electronic document;where the sale of imported vaccines, he shall also provide a copy of the customs clearance form of imported drugs affixed to his seal or an electronic document.

　　When receiving or purchasing a vaccine, the disease prevention and control agency or inoculation unit shall obtain the supporting documents provided for in the preceding paragraph and keep them for reference not less than five years after the expiration of the validity period of the vaccine.

　　Article 39 the holder of a vaccine marketing license shall, in accordance with the provisions, establish a true, accurate and complete sales record and keep it for not less than five years after the expiration of the validity period of the vaccine for reference.

　　The disease prevention and control agencies, inoculation units and vaccine distribution units shall, in accordance with the provisions, establish true, accurate and complete records of receipt, purchase, storage, distribution and supply, and keep them for reference not less than five years after the expiration of the validity period of the vaccine.

　　When a disease prevention and control agency or inoculation unit receives or purchases a vaccine, it shall obtain a record of temperature monitoring of the whole process of transportation and storage, and keep it for reference not less than five years after the expiration of the validity period of the vaccine;if it is unable to provide a record of temperature monitoring of the whole process of transportation and storage or the temperature control does not meet the requirements, it shall not receive or purchase it, and shall immediately report it to the drug supervision and Administration Department and the department in charge of Health and health of the local people’s government at or above the county level.

　　Article 40 disease prevention and control institutions and inoculation units shall establish a system of regular inspection of vaccines, take measures such as isolation and Storage, setting up warning signs and other measures for vaccines that have problems such as unrecognized packaging, non-conforming storage temperatures and exceeding the validity period, and dispose of them in accordance with the provisions of the drug supervision and Administration Department under the state council, the department in charge of Health and health and the department in charge of Ecology and environment.The agency for Disease Prevention and control and the inoculation unit shall truthfully record the disposition, and the disposition record shall be kept for not less than five years after the expiration of the validity period of the vaccine for reference.

Chapter V vaccination

　　Article 41 the competent Department of Health and health under the state council shall formulate a national immunization plan;the types of vaccines in the national immunization plan shall be drawn up by the competent Department of Health and health under the state council in conjunction with the financial department under the state council, which shall be reported to the State Council for approval and published.

　　The competent Department of Health and health under the state council shall establish an Expert Advisory Committee on national immunization planning and, in conjunction with the financial Department of the state council, shall establish a mechanism for the dynamic adjustment of vaccine types in national immunization planning.

　　When implementing the national immunization plan, the people’s governments of provinces, autonomous regions and municipalities directly under the central government may, in accordance with the needs of disease prevention and control in their respective administrative areas, increase the types of vaccines for the immunization plan and report it to the department in charge of Health and health under the State Council for the record and publish it.

　　Article 42 the competent Department of Health and health under the state council shall formulate and publish norms for the work of inoculation and strengthen the standardized management of inoculation prevention.

　　The competent Department of Health and health under the state council shall formulate and publish the immunization procedures for vaccines under the national immunization plan and the guiding principles for the use of vaccines under the non-immunization plan.

　　The departments in charge of Health and health of the people’s governments of provinces, autonomous regions and municipalities directly under the central government shall formulate vaccination plans in the light of the actual situation in their respective administrative areas and report them to the departments in charge of Health and health of the State Council for the record.

　　Article 43 disease prevention and control institutions at various levels shall, in accordance with their respective responsibilities, carry out publicity, training, technical guidance, monitoring, evaluation, epidemiological investigation, emergency response and other work related to vaccination.

　　Article 44 inoculation units shall meet the following conditions：

　　(1)obtaining a license to practice in a medical institution;

　　(2)qualified physicians, nurses or Rural Doctors With professional inoculation training and assessment organized by the competent health and health departments of the people’s governments at the county level;

　　(3)have refrigeration facilities, equipment and refrigeration storage systems that comply with the norms of vaccine storage and transportation management.

　　The competent Department of Health and health of the local people’s governments at or above the county level designates qualified medical institutions to undertake immunization planning and vaccination work in the area of responsibility.A qualified medical institution may undertake the work of non-immunization planning vaccination and shall report it to the competent Department of Health and health that issued the practice license of its medical institution for the record.

　　Inoculation units shall strengthen their internal management,and inoculation work shall comply with the norms of inoculation work, immunization procedures, guidelines for the use of vaccines and inoculation programmes.

　　Disease prevention and control institutions at all levels shall strengthen the technical guidance of vaccination units and the management of the use of vaccines.

　　Article 45 when inoculating, medical and health personnel shall inform the recipient or his or her guardian of the variety, role, taboos, adverse reactions and other precautions for vaccination, inquire about the state of health of the recipient and whether there are taboos for vaccination, etc., and truthfully record the information and inquiry.The recipient or his or her guardian shall truthfully provide the recipient’s health status and contraindications for inoculation.If there is a taboo against inoculation and cannot be inoculated, medical and health personnel shall make medical recommendations to the recipient or his or her guardian, and truthfully record the situation of making medical recommendations.

　　Before carrying out vaccination, medical and health personnel shall, in accordance with the requirements of the norms of vaccination work, check the health status of the recipient, verify the taboo against vaccination, check the vaccination certificate, check the appearance, batch number and expiration date of the vaccine and syringe, check the name, age and name, specifications, dosage, site of vaccination and route of vaccination of the recipient, so that the recipient, vaccination certificate and vaccine information are consistent, and the vaccination can be carried out before confirmation is correct.

　　Medical and health personnel shall inoculate those who meet the conditions for vaccination.Where adverse reactions occur during the stay of the seed recipient at the scene, medical and health personnel shall take timely treatment and other measures in accordance with the requirements of the norms of inoculation prevention work.

　　Article 46 medical and health personnel shall, in accordance with the provisions of the competent Department of Health and health under the state council, record truthfully, accurately and completely the identification information of the variety of vaccines, the holder of the listing license, the smallest packing unit, the validity period, the time of inoculation, the medical and health personnel who carried out the inoculation, the seed recipient and other inoculation information, so as to ensure that the inoculation information can be traced and queried.Vaccination records shall be kept for not less than five years after the expiration of the validity period of the vaccine for reference.

　　Article 47 the state shall implement a system of vaccination certificates for children.Within one month after the birth of the child, his or her guardian shall go to the inoculation unit or birth hospital where the child is living to undertake the work of inoculation and apply for the inoculation certificate for him or her.Inoculation units or birth hospitals may not refuse to handle them.The guardian shall keep the vaccination certificate properly.

　　Vaccination shall be administered by the place of residence, and the vaccination unit responsible for the vaccination of the child while he or she leaves his or her place of residence shall be responsible for the vaccination of the child during the period of his or her departure from his or her place of residence.

　　The format of the vaccination certificate shall be prescribed by the department in charge of Health and health under the state council.

　　Article 48 when a child enters or attends school, the child-care institution or school shall examine the vaccination certificate and find that the vaccine has not been vaccinated in accordance with the provisions of the immunization plan, it shall report it to the inoculation unit in the place of residence of the child or the place of the child-care institution or school that undertakes the prevention work of inoculation, and cooperate with the inoculation unit to urge his or her guardian to replant the vaccine in accordance with the provisions.Disease prevention and control institutions shall provide technical guidance for child-care institutions and schools to check vaccination certificates.

　　Measures for the examination of children & apos; s admission and admission to school for vaccination certificates shall be formulated by the competent Department of Health and health under the state council in conjunction with the Administrative Department of Education under the state council.

　　Article 49 inoculation units shall not charge any fees for vaccinations under the immunization plan.

　　In addition to the cost of the vaccine, the vaccination unit may also charge a vaccination service fee.The fees for vaccination service fees shall be set by the price departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government in conjunction with the financial departments.

　　Article 50 the competent Department of Health and health of the local people’s governments at or above the county level may, on the basis of information on monitoring and early warning of infectious diseases, report it to the competent Department of Health and health of the people’s governments at the corresponding level for the purpose of preventing and controlling outbreaks and epidemics of infectious diseases and report it to the competent Department of health of the people’s governments at or above the provincial level for the record, and may conduct mass vaccination in their respective administrative areas.

　　Where it is necessary to carry out group vaccination throughout the country or within the scope of provinces, autonomous regions or municipalities directly under the central government, the department in charge of Health and health under the state council shall decide.

　　The local people’s government at or above the county level or the competent Department of Health and health under the state council shall organize the relevant departments to do a good job of Personnel Training, publicity and education, material mobilization and so on.

　　No unit or individual may carry out group inoculation without authorization.

　　Article 51 in the event of an outbreak or epidemic of an infectious disease, the local people’s governments at or above the county level or their departments in charge of Health and health need to take emergency vaccination measures, in accordance with the provisions of laws and administrative rules and regulations.

Chapter VI monitoring and handling of abnormal reactions

　　Article 52 abnormal inoculation reaction refers to the adverse reaction of drugs caused by qualified vaccines during the implementation of standardized inoculation or after the implementation of standardized inoculation, which has caused damage to the tissues, organs and functions of the recipient’s body, and none of the relevant parties have been at fault.

　　The following conditions are not abnormal inoculation reactions：

　　(I)general post-vaccination reaction due to the characteristics of the vaccine itself;

　　(II)damage caused to seed recipients due to vaccine quality problems;

　　(3)damage caused to the recipient by the inoculation unit in violation of the norms of inoculation work, immunization procedures, guidelines for the use of vaccines, and inoculation programs;

　　(4) the recipient at the time of inoculation is in the incubation period or precursor period of a disease, after inoculation coupling onset;

　　(5) the recipient has a vaccination taboo specified in the vaccine specification, before vaccination the recipient or his guardian did not truthfully provide the recipient’s health status and vaccination taboo, etc., after vaccination the recipient of the original disease acute recurrence or exacerbation of the disease.;

　　(6)the psychological response of an individual or group due to psychological factors.

　　Article 53 the state shall strengthen the monitoring of abnormal responses to vaccination.The plan for monitoring the abnormal response to vaccination shall be formulated by the competent Department of Health and health under the state council in conjunction with the Department of drug supervision and administration under the state council.

　　Article 54 Where inoculation units,medical institutions, etc. find a suspected abnormal reaction to inoculation, they shall report it to the disease prevention and control institutions in accordance with the provisions.

　　The holder of a vaccine marketing license shall set up a specialized agency with full-time personnel to collect, track and analyze suspected abnormal reactions to vaccination on his own initiative, take timely risk control measures, report suspected abnormal reactions to vaccination to the disease prevention and Control Agency, and submit the quality analysis report to the pharmaceutical supervision and administration departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government.

　　Article 55 the agency for Disease Prevention and control shall promptly report the suspected abnormal response to inoculation in accordance with the provisions, organize an investigation and diagnosis, and inform the recipient or his or her guardian of the conclusions of the investigation and diagnosis.Where there is a dispute over the conclusion of the investigation or diagnosis, an application may be made for appraisal in accordance with the appraisal measures formulated by the competent Department of Health and health under the state council.

　　Any suspected abnormal reaction to vaccination that has a significant impact on society, such as the death or serious disability of the person receiving the vaccination as a result of vaccination, or the suspected abnormal reaction of the group to vaccination, shall be investigated and dealt with by the departments in charge of Health and drug supervision and administration of the people’s governments at or above the municipal level divided into districts in accordance with their respective responsibilities.

　　Article 56 the state shall implement a system of compensation for abnormal reactions in vaccination.Where the death, severe disability, organ and tissue damage of the recipient during or after the vaccination is carried out is an abnormal reaction to vaccination or cannot be ruled out, compensation shall be given.The compensation range implements directory management and dynamically adjusts according to the actual situation.

　　The compensation costs required for vaccination against immunization planning vaccines shall be arranged by the financial departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government in the funding for vaccination;the compensation costs required for vaccination against non-immunization planning vaccines shall be borne by the holder of the relevant vaccine marketing license.The state encourages compensation for recipients of abnormal inoculation responses through various forms, such as commercial insurance.

　　Compensation for abnormal response to inoculation shall be timely, convenient and reasonable.The scope, standards and procedures for compensating for abnormal reactions in vaccination shall be prescribed by the state council, and the provinces, autonomous regions and municipalities directly under the central government shall formulate specific measures for their implementation.

Chapter VII post-market Administration of vaccines

　　Article 57 the holder of a vaccine listing license shall establish and improve the quality management system of the whole life cycle of the vaccine, formulate and implement a post-market risk management plan for the vaccine, carry out post-market research on the vaccine, and further confirm the safety, effectiveness and quality control of the vaccine.

　　For a vaccine that puts forward further research requirements when approving an application for vaccine registration, the holder of the vaccine marketing license shall complete the research within the prescribed time limit;if the research is not completed within the prescribed time limit or the benefit is not proved to be greater than the risk, the drug supervision and Administration Department under the State Council shall deal with it according to law until the drug registration certificate of the vaccine is cancelled.

　　Article 58 the holder of the Vaccine Market License shall carry out quality tracking and analysis of the vaccine, continuously improve the quality control standards, improve the production process and improve the stability of the production process.

　　Where there is a change in production technology, production site, key equipment, etc., it shall be evaluated and verified and filed or reported in accordance with the provisions of the drug supervision and Administration Department under the State Council on Change Management;where the change may affect the safety, effectiveness and quality control of vaccines, it shall be approved by the drug supervision and Administration Department under the state council.

　　Article 59 the holder of a vaccine listing license shall continuously update the specification and label in accordance with the post-market research of the vaccine and the abnormal reaction of vaccination, and apply for approval or filing in accordance with the provisions.

　　The pharmaceutical supervision and Administration Department under the state council shall publish the updated vaccine instructions and labels on its website in a timely manner.

　　Article 60 the holder of a Vaccine Market License shall establish a system of review and analysis of vaccine quality and risk reporting, and truthfully report to the pharmaceutical supervision and Administration Department under the State Council on the production and circulation of vaccines, post-market research and risk management, etc. every year in accordance with the provisions.

　　Article 61 the drug supervision and Administration Department under the state council May, according to the actual situation, order the holder of the vaccine listing license to carry out post-listing evaluation or directly organize post-listing evaluation.

　　The drug supervision and Administration Department under the state council shall cancel the drug registration certificate of the vaccine for which the abnormal response to vaccination is serious or for other reasons endangers human health.

　　Article 62 the pharmaceutical supervision and Administration Department under the state council may, in accordance with the needs for Disease Prevention and control and the development of the vaccine industry, organize post-market evaluation of vaccine varieties and find that the product design, production technology, safety, effectiveness or quality control of such vaccine varieties is significantly inferior to other vaccine varieties for the prevention and control of the same disease, shall cancel the drug registration certificate of all vaccines of such varieties and annul the corresponding national drug standards.

Chapter VIII safeguards

　　Article 63 people’s governments at or above the county level shall include in the budget of the government at the corresponding level the necessary funds for Vaccine Safety, the purchase of vaccines for immunization planning and vaccination, as well as the construction of information technology, so as to ensure the implementation of the immunization planning system.

　　The people’s governments at the county level shall, in accordance with the relevant provisions of the state, grant subsidies to rural doctors and other primary medical and health personnel engaged in vaccination prevention.

　　The state supports vaccination efforts in economically underdeveloped areas as needed.The people’s governments of provinces, autonomous regions and municipalities directly under the central government and the people’s governments at the municipal level divided into districts shall grant necessary financial subsidies to the people’s governments at the county level in economically underdeveloped areas to carry out work related to inoculation prevention.

　　Article 64 the people’s governments of provinces, autonomous regions and municipalities directly under the central government, in accordance with the epidemic trends of infectious diseases in their respective administrative areas, shall, within the scope of the projects for the prevention and control of infectious diseases determined by the competent Department of Health and health under the state council, determine the projects related to vaccination in their respective administrative areas and ensure the implementation of the projects.

　　Article 65 the competent Department of Health and health under the State Council shall, in accordance with the plan for the use of vaccines under the national immunization plan of all provinces, autonomous regions and municipalities directly under the central government, provide information on the needs of vaccines under the national immunization plan to the holder of the vaccine listing license, and the holder of the vaccine listing license shall rationally arrange production on the basis of the information on the needs of vaccines.

　　When there is a risk of shortage in supply of vaccines, the competent Department of Health and health under the state council and the Department of pharmaceutical supervision and administration under the state council make recommendations, and the competent Department of industry and Information Technology under the state council and the Department of Finance under the state council shall take effective measures to ensure the production and supply of vaccines.

　　The holder of the Vaccine Market License shall organize production according to law to ensure the supply of vaccines;where the holder of the Vaccine Market License stops the production of vaccines, he shall promptly report to the pharmaceutical supervision and Administration Department under the state council or the pharmaceutical supervision and Administration Department of the people’s government of a province, autonomous region or municipality directly under the central government.

　　Article 66 the state shall incorporate vaccines into its reserves of strategic materials, and shall implement reserves at the central and provincial levels.

　　The competent Department of industry and Information Technology and the financial Department of the state council, together with the competent Department of Health and health, the Department of Public Security, the Department of market supervision and administration and the Department of pharmaceutical supervision and administration, strengthen the production capacity and product management of vaccine reserves and establish dynamic adjustment mechanisms in accordance with the needs of disease prevention, control and emergency preparedness for public health.

　　Article 67 the funds used for inoculation prevention in financial arrangements at various levels shall be earmarked for special purposes, and no unit or individual may misappropriate or squeeze in them.

　　Units and individuals concerned shall, according to law, accept the audit supervision of audit institutions for the use of funds for vaccination.

　　Article 68 the state implements a compulsory insurance system for vaccine liability.

　　The holder of the vaccine marketing license shall apply for compulsory insurance of vaccine liability in accordance with the provisions.If the damage caused by the quality of the vaccine is caused by the seed recipient, the Insurance Company shall pay the compensation within the limit of the liability covered.

　　The specific measures for the implementation of the compulsory insurance system for vaccine liability shall be formulated by the pharmaceutical supervision and Administration Department under the state council in conjunction with the competent health and health departments and insurance supervision and administration agencies under the state council.

　　Article 69 in the event of an outbreak or epidemic of an infectious disease, the holder of the relevant vaccine marketing license shall produce and supply vaccines for the prevention and control of infectious diseases in a timely manner.Transportation units shall give priority to transporting vaccines for the prevention and control of infectious diseases.The people’s governments at or above the county level and their relevant departments shall do a good job of organizing, coordinating and safeguarding.

Chapter IX supervision and management

　　Article 70 the pharmaceutical supervisory and administrative departments and the departments in charge of Health and health shall, in accordance with their respective responsibilities, supervise and manage the whole process of vaccine development, production, circulation and vaccination, and supervise the implementation of their obligations according to law by the holders of vaccine marketing licenses, disease prevention and control institutions and inoculation units.

　　The pharmaceutical supervision and administration departments shall, in accordance with law, supervise and inspect the quality of vaccines in vaccine development, production, storage, transportation and inoculation.The competent departments of Health and health shall, according to law, supervise and inspect the implementation of the immunization planning system and inoculation prevention activities.

　　The pharmaceutical supervision and administration department shall strengthen on-site inspection of the holders of the vaccine market license;when necessary, it may extend inspection of units and individuals that provide products or services for Vaccine Development, Production and circulation activities;units and individuals concerned shall cooperate and may not refuse or conceal them.

　　Article 71 the state shall build a professional and specialized team of drug inspectors at the central and provincial levels and strengthen supervision and inspection of vaccines.

　　The pharmaceutical supervision and administration departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government appoint inspectors to settle the holders of vaccine marketing licenses.The inspectors are responsible for supervising and inspecting the implementation of the quality management standards for pharmaceutical production, collecting clues on vaccine quality risks and violations of laws and regulations, reporting the situation to the pharmaceutical supervision and administration departments of the people’s governments of provinces, autonomous regions and municipalities directly under the central government and making recommendations, and are responsible for their actions during the period of assignment.

　　Article 72 where there are safety risks in vaccine quality management, and the holders of vaccine marketing licenses fail to take timely measures to eliminate them, the drug supervision and Administration Department may take measures such as responsible interviews and rectification within a time limit.

　　Where there is a serious violation of drug-related quality management standards, the drug supervision and administration department shall order the suspension of vaccine production, sales and distribution, and immediately rectify it;after the completion of the rectification, the drug supervision and administration department shall check to meet the requirements before resuming production, sales and distribution.

　　The pharmaceutical supervision and administration department shall establish a system of credit records for holders of vaccine marketing licenses and their relevant personnel, incorporate them into the national credit information sharing platform, publicize their serious untrustworthy information in accordance with the provisions, and implement joint disciplinary measures.

　　Article 73 where a vaccine exists or is suspected of having quality problems, the holder of the vaccine marketing license, the disease prevention and control agency or the inoculation unit shall immediately stop selling, distributing or using it, immediately stop production if necessary, and report it to the pharmaceutical supervision and Administration Department and the department in charge of Health and health of the people’s government at or above the county level in accordance with the provisions.The competent Department of Health and health shall immediately organize the organs for Disease Prevention and control and inoculation units to take the necessary emergency measures, and at the same time report to the competent Department of Health and health of the people’s government at a higher level.The drug supervision and administration department shall take measures such as seizure and seizure according to law.For vaccines that have been sold, the holder of the vaccine marketing license shall promptly notify the relevant disease prevention and control institutions, vaccine distribution units and vaccination units, recall in accordance with the provisions, truthfully record the recall and notification, and the disease prevention and control institutions, vaccine distribution units and vaccination units shall cooperate.

　　Where the production, sale, distribution, use or recall of vaccines is not stopped in accordance with the provisions of the preceding paragraph, the pharmaceutical supervision and Administration Department and the department in charge of Health and health of the people’s governments at or above the county level shall, in accordance with their respective duties, order the production, sale, distribution, use or recall of vaccines.

　　The holder of the vaccine marketing license, the disease prevention and control agency or the inoculation unit shall not conceal, misrepresent, delay or underreport the vaccine, and shall not conceal, falsify or destroy relevant evidence if it is found to have or suspected to have quality problems.

　　Article 74 the holder of a vaccine marketing license shall establish an information disclosure system and, in accordance with the provisions, promptly disclose on his website information on vaccine products, instructions and labels, the implementation of drug-related quality management standards, the status of approval and issuance, the status of recall, the status of inspection and punishment, and the status of compulsory insurance for the responsibility to insure vaccines.

　　Article 75 the pharmaceutical supervision and Administration Department under the state council, in conjunction with the competent Department of Health and health under the state council, shall establish mechanisms for sharing information on vaccine quality and inoculation.

　　The pharmaceutical supervision and administration departments of the people’s governments at or above the provincial level, the departments in charge of Health and health, etc. shall, in accordance with the principles of science, objectivity, timeliness and openness, organize the holders of vaccine marketing licenses, disease prevention and control institutions, inoculation units, news media, scientific research units, etc., to exchange and communicate information on vaccine quality and inoculation.

　　Article 76 the state shall implement a unified system of disclosure of vaccine safety information.

　　Warning information on vaccine safety risks, information on major vaccine safety accidents and their investigation and handling, and other vaccine safety information determined by the state council to be uniformly published, shall be published by the pharmaceutical supervision and Administration Department under the state council in conjunction with the relevant departments.The report on the abnormal response to vaccination in the country shall be uniformly published by the competent Department of Health and health under the state council in conjunction with the Department of drug supervision and administration under the state council.The above information may not be published without authorization.The publication of major vaccine safety information shall be timely, accurate and comprehensive, and scientific assessment shall be carried out in accordance with the provisions and the necessary explanations shall be made.

　　When the drug supervision and Administration Department of the people’s government at or above the county level discovers vaccine safety information that may mislead the public and public opinion, it shall immediately verify and analyze it with the competent Department of Health and other relevant departments, professional institutions and holders of relevant vaccine marketing licenses, and publish the results in a timely manner.

　　No unit or individual shall fabricate or disseminate false vaccine safety information.

　　Article 77 any unit or individual shall have the right to obtain vaccine information according to law and to put forward opinions and suggestions on the supervision and administration of vaccines.

　　Any unit or individual has the right to report illegal acts of vaccines to the departments in charge of Health and health, the departments in charge of drug supervision and administration and other departments, and to report cases where the departments in charge of Health and health, the departments in charge of drug supervision and administration and their staff have not performed their duties of supervision and administration in accordance with law to the people’s governments at the corresponding level or at a higher level and their relevant departments and supervision organs.Relevant departments and organs shall promptly verify and deal with;to verify the truth of the report, in accordance with the provisions of the whistleblower reward; whistleblower to report serious illegal acts in the unit where the report is verified, to give a heavy Award.

　　Article 78 the people’s governments at or above the county level shall formulate emergency plans for vaccine safety incidents, and make provisions on the classification of vaccine safety incidents, the organizational command system and responsibilities for the disposal, the mechanism of prevention and early warning, the procedures for the disposal and emergency security measures.

　　The holder of the vaccine listing license shall formulate a plan for the disposal of vaccine safety incidents, regularly check the implementation of various preventive measures, and eliminate security risks in a timely manner.

　　In the event of a vaccine safety incident, the holder of the vaccine marketing license shall immediately report it to the drug supervision and Administration Department under the state council or the drug supervision and Administration Department under the people’s governments of provinces, autonomous regions and municipalities directly under the central government;the disease prevention and control agencies, inoculation units and medical institutions shall immediately report it to the health and health departments and drug supervision and administration departments of the people’s governments at or above the county level.The drug supervision and administration department shall, together with the department in charge of Health and health, in accordance with the provisions of the emergency plan, set up a command body for the disposal of vaccine safety incidents, carry out medical treatment, risk control, investigation and processing, information dissemination, explanation and explanation, and do a good job in the disposal of replanting and other post-treatment work.Replanting costs for vaccine safety incidents due to quality problems are borne by the holder of the vaccine marketing license.

　　Units and individuals concerned may not conceal, misrepresent, delay or underreport vaccine safety incidents, and may not conceal, forge or destroy relevant evidence.
Chapter X legal liability

　　Article 79 whoever, in violation of the provisions of this law, constitutes a crime shall be investigated for criminal responsibility in accordance with law.

　　Article 80 where the production and sale of vaccines are counterfeit drugs, the pharmaceutical supervision and Administration Department of the people’s government at or above the provincial level shall confiscate the illegal income and the vaccines produced and sold illegally, as well as the raw materials, accessories, packaging materials and equipment specially used for the illegal production of vaccines, order the suspension of production and rectification, revoke the drug registration certificate until the drug production license is revoked, and impose a fine of not less than 15 times the value of the illegal production and sale of vaccines, and not less than 50 times the value of the goods, which is less than 500,000 yuan, on the basis of 500,000 yuan.

　　Where the production and sale of vaccines are inferior drugs, the pharmaceutical supervision and Administration Department of the people’s government at or above the provincial level shall confiscate the illegal income and the vaccines produced and sold illegally, as well as the raw materials, accessories, packaging materials, equipment and other items specially used for the illegal production of vaccines, order the suspension of production and rectification, and impose a fine of not less than 10 times the value of the illegal production and sale of vaccines, not less than 30 times the value of the illegal production and sale of vaccines, which shall be calculated as 500,000 yuan;if the circumstances are serious, the certificate of registration of drugs shall be revoked until the license for the production of drugs is revoked, etc.

　　Where the production or sale of vaccines are counterfeit drugs, or the production or sale of vaccines are inferior drugs and the circumstances are serious, the pharmaceutical supervision and Administration Department of the people’s government at or above the provincial level shall confiscate the income earned from their units during the time of the illegal act, impose a fine of not less than one time but not more than ten times the income received, prohibit the production and sale of drugs for life, and detain the public security organ for not less than five days but not more than 15 days.

　　Article 81 in any of the following circumstances, the pharmaceutical supervision and Administration Department of the people’s government at or above the provincial level shall confiscate the illegal income and the vaccines illegally produced and sold, as well as the raw materials, accessories, packaging materials and equipment specially used for the illegal production of vaccines, order the suspension of production and rectification, and impose a fine of not less than 15 times the value of the illegal production and sale of vaccines, not less than 50 times the value of the illegal production and sale of vaccines, and a fine of not less than 500,000 yuan, which shall be calculated on the basis of 500,000 yuan;if the circumstances are serious, the relevant approval documents for drugs shall be revoked, until the license for the production of drugs is revoked, etc., to the legal representative, the main person-in-charge or the person directly responsible for the illegal production and sale of vaccines. the persons in charge, the personnel in key positions and other persons responsible shall confiscate the income earned from their units during the period when the illegal act occurs, and shall also impose a fine of not less than 50% but not more than 10 times the income received, and shall be prohibited from engaging in pharmaceutical production and business activities for ten years until life, and shall be detained by the public security organ for not less than 5 days but not more than 15 days：

　　(1)application for vaccine clinical trials,registration,approval and issuance, provision of false data,materials,samples or other fraudulent acts;

　　(2)fabricating production, inspection records or changing product lot numbers;

　　(3)supply of vaccines to vaccination units by units or individuals other than disease prevention and control institutions;

　　(IV)commissioned production of vaccines without approval;

　　(5)changes in the production process, production site, key equipment, etc. shall be approved but not approved in accordance with the provisions;

　　(6)updating the vaccine instructions and labels shall be approved but not approved in accordance with the provisions.

　　Article 82 except as otherwise provided in this law, the holder of a vaccine marketing license or other unit who violates the quality management standards related to drugs shall be ordered by the drug supervision and Administration Department of the people’s government at or above the county level to make corrections and give a warning;if he refuses to make corrections, he shall be fined not less than 200,000 yuan but not more than 500,000 yuan;if the circumstances are serious, he shall be fined not less than 500,000 yuan but not more than 3 million yuan, and he shall be ordered to stop production and business for rectification, until the relevant approval documents for drugs, the drug production license, etc. are revoked, and the legal representative, the main person-in-charge, the person-in-charge directly in charge and the personnel in key positions and other persons responsible for them shall be fined not less than 500,000 yuan and not more than 300,000 yuan are suspended he shall also impose a fine of not less than 50% but not more than five times the income obtained, and shall be prohibited from engaging in pharmaceutical production and business activities for ten years until life.

　　Article 83 in violation of the provisions of this law, the holder of the vaccine marketing license has any of the following circumstances, by the people’s government at or above the provincial level drug supervision and Administration Department ordered to correct,give a warning;refuse to correct,a fine of 200,000 yuan to 500,000 yuan; serious circumstances, ordered to stop production and business rectification,and a fine of 500,000 yuan to 2 million yuan：

　　(I)failure to establish an electronic traceability system for vaccines in accordance with the provisions;

　　(2)the legal representative,the main person-in-charge and the person-in-charge of Production Management, Quality Management person-in-charge, quality authorized person and other key positions do not meet the prescribed conditions or do not train or assess them in accordance with the provisions.;

　　(3)failure to report or record in accordance with the provisions;

　　(4)failure to carry out post-market research in accordance with the provisions, or failure to set up institutions and personnel in accordance with the provisions of the initiative to collect,track and analyze suspected inoculation abnormal response;

　　(5)failure to apply for compulsory insurance of vaccine liability in accordance with the provisions;

　　(6) the information disclosure system has not been established in accordance with the provisions.

　　Article 84 in violation of the provisions of this law, the approval and issuance agency has any of the following circumstances, the drug supervision and Administration Department under the State Council ordered to make corrections,give a warning,the main person in charge, directly responsible for the person in charge and other directly responsible personnel given a warning according to law until the downgrade：

　　(A)failure to conduct audit and inspection in accordance with the provisions;

　　(2)failure to publish the results of the approval and issuance of listed vaccines in a timely manner;

　　(III)failure to verify as required;

　　(IV)significant quality risks of vaccines were found not to be reported as required.

　　If, in violation of the provisions of this law, the issuing authority fails to issue a certificate of approval and issuance in accordance with the provisions or fails to issue a notice of approval and issuance, the drug supervision and Administration Department under the state council shall order it to make corrections, give a warning, and give demotion or dismissal to the main person-in-charge, the person-in-charge directly responsible and other persons-in-charge directly responsible according to law;if the circumstances are serious, the main person-in-charge directly responsible and other persons-in-charge directly responsible according to law.

　　Article 85 where a disease prevention and control agency, inoculation unit, vaccine listing license holder or vaccine distribution unit violates the cold chain storage and transportation requirements of the vaccine storage and transportation regulations, the pharmaceutical supervision and Administration Department of the people’s government at or above the county level shall order it to correct, give a warning, destroy the vaccines illegally stored and transported and confiscate the illegal income;if it refuses to correct, a fine of 200,000 yuan to 1 million yuan to the vaccination unit, vaccine listing license holder or vaccine distribution unit shall be imposed;if the circumstances are serious, the vaccination unit, vaccine listing license holder or vaccine distribution unit shall be fined if the value of the goods is less than 100,000 yuan, the holder of the vaccine marketing license and the vaccine distribution unit shall be ordered to stop production and shut down business for rectification, until the relevant approval documents for drugs and the drug production license are revoked, and the legal representatives of the vaccine marketing license holder, the main person-in-charge, the person-in-charge directly responsible and the personnel in key positions and other persons responsible shall be punished in accordance with the provisions of Article 82 of this law.

　　Where a disease prevention and control institution or inoculation unit commits an illegal act as provided for in the preceding paragraph, the competent Department of Health and health of the people’s government at or above the county level shall give a warning to the main person-in-charge, the person-in-charge directly in charge and other persons directly responsible for the act until they are removed from their posts according to law, and order the medical and health personnel responsible for the act to suspend their practice activities for not less than one year but not more than 18 months;if serious consequences are caused, the main person-in-charge, the person-in-charge directly in charge and other persons directly responsible for the act to be expelled according to law, and the qualification of the inoculation unit may be revoked, and the original licensing department shall revoke the practice certificate of the medical and health personnel responsible for the act.

　　Article 86 where a disease prevention and control agency, vaccination unit, vaccine listing license holder or vaccine distribution unit commits any act other than the provisions of Article 85 of this law in violation of the standard management of vaccine storage and transportation, the pharmaceutical supervision and Administration Department of the people’s government at or above the county level shall order it to make corrections, give a warning and confiscate the illegal income;if it refuses to make corrections, a fine of not less than 100,000 yuan but not more than 300,000 yuan is imposed on the vaccination unit, the vaccine listing license holder or the vaccine distribution unit;if the circumstances are serious, a fine of not more than three times the value of the vaccine stored and transported illegally by the vaccination unit, the vaccine listing license holder or the vaccine distribution unit shall be not less than 10 times the value of the vaccine stored and transported illegally, and the value of the vaccine shall be not less than 10 times the value of the vaccine stored and transported illegally, and the value of the vaccine shall be not less than 10 times the value of the vaccine stored and transported illegally, and the value of the vaccine shall be less than 100,000 yuan, according to 100,000 yuan calculation.

　　Where a disease prevention and control institution or inoculation unit commits an illegal act as provided for in the preceding paragraph, the competent Department of Health and health of the people’s government at or above the county level may give a warning to the main person-in-charge, the person-in-charge directly in charge and the other person-in-charge directly responsible until he is removed from office according to law, order the medical and health personnel who are responsible to suspend their practice activities for not less than six months but not more than one year;if serious consequences are caused, the main person-in-charge directly in charge and the other person-in-charge directly responsible shall be expelled according to law, and the original licensing department shall revoke the practice certificates of the medical and health personnel who are responsible for the practice.

　　Article 87 if, in violation of the provisions of this law, a disease prevention and control agency or inoculation unit commits any of the following circumstances, the competent Department of Health and health of the people’s government at or above the county level shall order it to make corrections, give a warning and confiscate the illegal income;if the circumstances are serious, the main person-in-charge, the person-in-charge directly responsible and the other person-in-charge directly responsible shall be given a warning according to law until the removal of his / her duties, and the medical and health personnel who are responsible shall be ordered to suspend their practice activities for not less than one year but not more than 18 months;if serious consequences are caused, the main person-in-charge directly responsible and the other person-in-charge directly responsible shall be expelled according to law, and the original licensing department shall be ordered to suspend his / her practice activities for not less than one year but not more than 18 months; if serious consequences are caused, the main person-in-charge, the person-in-charge directly responsible and the other person-in-charge directly responsible shall be expelled according to law, and the original licensing department shall revocation of the practice certificate of the responsible medical and health personnel：

　　(1)failure to supply, receive and procure vaccines in accordance with the provisions;

　　(II)vaccination does not comply with the guidelines for vaccination work, immunization procedures,guidelines for the use of vaccines, vaccination programmes;

　　(3)carrying out group vaccination without authorization.

　　Article 88 if, in violation of the provisions of this law, a disease prevention and control agency or inoculation unit commits any of the following circumstances, the competent Department of Health and health of the people’s government at or above the county level shall order it to make corrections and give a warning;if the circumstances are serious, the main person-in-charge, the person-in-charge directly responsible and other persons directly responsible shall be given a warning according to law until they are removed from their posts, and the medical and health personnel responsible shall be ordered to suspend their practice activities for not less than six months but not more than one year;if serious consequences are caused, the main person-in-charge, the person-in-charge directly responsible and the other persons directly responsible shall be expelled according to law, and the original licensing department shall revoke the person-in-charge who is directly responsible and the other persons directly responsible shall be suspended from their practice activities for not less than six months and not more than one year; if serious consequences are caused, the main person-in-charge, the person-in-charge directly responsible and the other persons directly responsible shall be expelled according to law, and the original licensing department shall revoke the certificate of practice of medical and health personnel：

　　(I)failure to provide retroactive information in accordance with the provisions;

　　(2)when receiving or purchasing vaccines, the relevant supporting documents and temperature monitoring records are not obtained and kept in accordance with the provisions.;

　　(3)failure to establish and maintain records of vaccine reception, purchase, storage, distribution, supply, vaccination and disposal in accordance with the provisions;

　　(4)failure to inform or inquire about the relevant circumstances of the recipient or his or her guardian in accordance with the provisions.

　　Article 89 where a disease prevention and control institution, inoculation unit or medical institution fails to report a suspected abnormal reaction to vaccination, vaccine safety incident, etc. in accordance with the provisions, or fails to organize an investigation or diagnosis of a suspected abnormal reaction to vaccination in accordance with the provisions, the competent Department of Health and health of the people’s government at or above the county level shall order it to make corrections and give a warning;if the circumstances are serious, the vaccination unit or medical institution shall be fined not less than 50,000 yuan but not more than 500,000 yuan, and the main person-in-charge of the disease prevention and control institution, inoculation unit or medical institution, the person-in-charge directly in charge and other persons who are directly responsible shall be given a warning according to law until they are removed from their posts;if there are serious consequences, the main person-in-charge, the person-in-charge directly in charge and other persons directly responsible shall be expelled according to law, and the original licensing department shall revoke the practice certificate of the medical and health personnel responsible.

　　Article 90 where a disease prevention and control institution or inoculation unit collects fees in violation of the provisions of this law, the competent Department of Health and health of the people’s government at or above the county level shall supervise the return of the fees illegally collected to the unit or individual who originally paid the fees, and shall be punished according to law by the market supervision and Administration Department of the people’s government at or above the county level.

　　Article 91 whoever, in violation of the provisions of this law, engages in immunization planning and vaccination work without the designation of the competent Department of Health and health of the local people’s government at or above the county level, or does not meet the conditions for non-immunization planning and vaccination work, shall be ordered by the competent Department of Health and health of the people’s government at or above the county level to make corrections, give a warning, confiscate the illegal income and the illegally held vaccines, order him to stop business for rectification, and impose a fine of not less than 100,000 yuan but not more than 1 million yuan, and impose sanctions on the main person-in-charge, the person-in-charge directly in charge and other persons who are directly responsible in accordance with the law.

　　Where, in violation of the provisions of this law, a disease prevention and control Institution, a unit or an individual other than an inoculation unit conducts mass vaccination without authorization, the competent Department of Health and health of the people’s government at or above the county level shall order it to make corrections, confiscate the illegal income and the vaccines held illegally, and impose a fine of not less than 10 times the value of the vaccines held illegally, but not more than 30 times the value of the vaccines held illegally, and if the value of the vaccines is less than 50,000 yuan, the value of the vaccines shall be calculated as 50,000 yuan.

　　Article 92 if a guardian fails to ensure that children of school age are vaccinated on time in accordance with law, the competent Department of Health and health of the people’s government at the county level shall criticize Education and order it to make corrections.

　　If a child-care institution or school fails to check the vaccination certificate in accordance with the provisions when a child is admitted to care or enrolled in school, or fails to report to the vaccination unit after discovering that a child has not been vaccinated in accordance with the provisions, the Education Administrative Department of the local people’s government at or above the county level shall order it to make corrections, give a warning, and impose sanctions on the main person-in-charge, the person-in-charge directly in charge and other persons who are directly responsible in accordance with the law.

　　Article 93 whoever fabricates or disseminates false vaccine safety information, or provokes quarrels and trouble in a vaccination unit, constitutes an act contrary to the administration of Public Security, shall be punished by the public security organ for the administration of Public Security in accordance with law.

　　Where newspapers, periodicals, radio, television, internet sites and other media fabricate or disseminate false vaccine safety information, the relevant departments shall be punished according to law, and the main person-in-charge, the person-in-charge directly in charge and other persons directly responsible shall be punished according to law.

　　Article 94 local people’s governments at or above the county level in the vaccine supervision and management work in any of the following circumstances, the directly responsible person in charge and other directly responsible person according to law to give demotion or removal of sanctions;if the circumstances are serious, according to law to give dismissal sanctions;causing serious consequences, the main person in charge：

　　(1)poor performance of duties, resulting in serious adverse effects or significant losses;

　　(2)false reporting,false reporting,slow reporting,underreporting vaccine safety incidents;

　　(3)interfere with or obstruct the investigation of vaccine violations or vaccine safety incidents;

　　(4)there have been particularly major vaccine safety accidents in their administrative areas, or major vaccine safety accidents have occurred continuously.

　　Article 95 drug supervision and administration departments,health and health departments and other departments in any of the following circumstances in the vaccine supervision and administration, the directly responsible person in charge and other directly responsible person according to law to give demotion or removal of sanctions;if the circumstances are serious,according to law to give dismissal sanctions;causing serious consequences, the main person in charge：

　　(1)failure to perform supervision and inspection duties, or found that illegal acts are not investigated and dealt with in a timely manner;

　　(2)unauthorized group inoculation;

　　(3)false reporting,false reporting,slow reporting,underreporting vaccine safety incidents;

　　(4)interfere with or obstruct the investigation of vaccine violations or vaccine safety incidents;

　　(5)disclosure of whistleblower information;

　　(6) received a suspected abnormal response to vaccination related reports, not in accordance with the provisions of the organization of Investigation,treatment;

　　(7)other acts that fail to perform their duties on vaccine supervision and management, resulting in serious adverse effects or significant losses.

　　Article 96 where damage is caused by vaccine quality problems, the holder of the vaccine marketing license shall be liable for compensation in accordance with law.

　　If a disease prevention and control agency or inoculation unit causes damage to the seed recipient due to violation of the norms of inoculation work, immunization procedures, guidelines for the use of vaccines and inoculation programs, it shall be liable for compensation in accordance with law.

Chapter XI supplementary provisions

　　Article 97 the meaning of the following terms in this law is：

　　Immunization planning vaccines refer to vaccines that residents should be vaccinated in accordance with the provisions of the government, including vaccines determined by the national immunization plan, vaccines added by the people’s governments of provinces, autonomous regions and municipalities directly under the central government in the implementation of the national immunization plan, as well as vaccines used by emergency vaccination or group vaccination organized by the people’s governments at or above the county level or their competent health departments.

　　Non-immunization programme vaccines refer to other vaccines voluntarily vaccinated by residents.

　　A holder of a vaccine listing license refers to an enterprise that has obtained a certificate of registration of vaccine drugs and a license for production of drugs in accordance with the law.

　　Article 98 the state encourages vaccine-producing enterprises to produce and export vaccines in accordance with international procurement requirements.

　　The exported vaccine shall comply with the standards or contractual requirements of the importing country(region).

　　Article 99 the purchase of entry-exit vaccinations and required vaccines shall be separately prescribed by the border health and quarantine organ in consultation with the financial department under the state council.

　　Article 100 this law shall come into force as of December 1, 2019.

William A. Haseltine

“These trials seem designed to prove their vaccines work, even if the measured effects are minimal”

Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are leading candidates for the completion of a Covid-19 vaccine likely to be released in the coming months. These companies have published their vaccine trial protocols. This unusually transparent action during a major drug trial deserves praise, close inspection of the protocols raises surprising concerns. These trials seem designed to prove their vaccines work, even if the measured effects are minimal.

What would a normal vaccine trial look like?

Prevention of infection must be a critical endpoint. Any vaccine trial should include regular antigen testing every three days to test contagiousness to pick up early signs of infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the ability of the vaccines to stave off infection. Prevention of infection is not a criterion for success for any of these vaccines. In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated. Measuring differences amongst only those infected by SARS-CoV-2underscores the implicit conclusion that the vaccines are not expected to prevent infection, only modify symptoms of those infected.

We all expect an effective vaccine to prevent serious illness if infected. Three of the vaccine protocols—Moderna, Pfizer, and AstraZeneca—do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache.

The greatest fear people have is dying from this disease. A vaccine must significantly or entirely reduce deaths from Covid-19. Over two hundred thousand people have died in the United States and nearly a million worldwide. None list mortality as a critical endpoint.

We recognize that the influenza vaccine does not prevent infection with that virus, but does have a measurable impact on hospitalization and death. The moderate protections from the influenza virus can potentially be replicated and improved on with Covid-19, but only with extensive trials that ensure the efficacy of a future vaccine.

Vaccine efficacy is typically proved by large clinical trials over several years. The pharmaceutical companies intend to do trials ranging from thirty thousand to sixty thousand participants. This scale of study would be sufficient for testing vaccine efficacy. The first surprise found upon a closer reading of the protocols reveals that each study intends to complete interim and primary analyses that at most include 164 participants.

These companies likely intend to apply for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) with just their limited preliminary results.

Interim analysis success requires a seventy percent efficacy. For Moderna, the interim analysis includes giving the vaccine to only 53 people. Their success margin is for 13 or less of those 53 to develop symptoms compared to 40 or more in their control group. For Johnson & Johnson, their interim analysis includes 77 vaccine recipients, with a success margin of 18 or less developing symptoms compared to 59 in the control group. For AstraZeneca, their interim analysis includes 50 vaccine recipients, with a success margin of 12 or less developing symptoms compared to 19 in the 25 person control group. Pfizer is even smaller in its success requirements. Their initial group includes 32 vaccine recipients, with a success margin of 7 or less developing symptoms compared to 25 in the control group.

The primary analyses are a bit more expanded, but need to be less efficacious for success: about sixty percent. AstraZeneca, Moderna, Johnson & Johnson, and Pfizer have primary analyses that distribute the vaccine to only 100, 151, 154, and 164 participants respectively. These companies state that they do not “intend” to stop trials after the primary analyses, but there is every chance that they intend to pursue an EUA and focus on manufacturing the vaccine rather than further thorough testing.

The second surprise from these protocols is how mild the requirements for contracted Covid-19 symptoms are. A careful reading reveals that the minimum qualification for a case of Covid-19 is a positive PCR test and one or two mild symptoms. These include headache, fever, cough, or mild nausea. This is far from adequate. These vaccine trials are testing to prevent common cold symptoms.

These trials certainly do not give assurance that the vaccine will protect from the serious consequences of Covid-19. Johnson & Johnson is the only trial that requires the inclusion of severe Covid-19 cases, at least 5 for the 75 participant interim analysis.

One of the more immediate questions a trial needs to answer is whether a vaccine prevents infection. If someone takes this vaccine, are they far less likely to become infected with the virus? These trials all clearly focus on eliminating symptoms of Covid-19, and not infections themselves. Asymptomatic infection is listed as a secondary objective in these trials when they should be of critical importance.

It appears that all the pharmaceutical companies assume that the vaccine will never prevent infection. Their criteria for approval is the difference in symptoms between an infected control group and an infected vaccine group. They do not measure the difference between infection and noninfection as a primary motivation.

A greater concern for the millions of older people and those with preexisting conditions is whether these trials test the vaccine’s ability to prevent severe illness and death. Again we find that severe illness and death are only secondary objectives in these trials. None list the prevention of death and hospitalization as a critically important barrier.

If total infections, hospitalizations, and death are going to be ignored in the preliminary trials of the vaccines, then there must be phase four testing to monitor their safety and efficacy. This would be long term massive scale monitoring of the vaccine. There must be an indication that the authorized vaccines are reducing infection, hospitalization, and death, or else they will not be able to stop this pandemic.

These protocols do not emphasize the most important ramifications of Covid-19 that people are most interested in preventing: overall infection, hospitalization, and death. It boggles the mind and defies common sense that the National Institute of Health, the Center for Disease Control, the National Institute of Allergy and Infectious Disease, and the rest would consider the approval of a vaccine that would be distributed to hundreds of millions on such slender threads of success.

It appears that these trials are intended to pass the lowest possible barrier of success. As this is being written, the FDA is poised to announce tougher standards for a Covid-19 vaccine in the near future. It is my hope that these new standards for an EUA will at a minimum include requirements for protections from infection itself, protections from severe virus-related disease leading to hospitalization, and a significant improvement in Covid-19 related mortality.

It is clear from these studies that the vaccines currently under trial will not be the silver bullet needed to end the pandemic. We must do all we can public health measures to control Covid-19 as China and other Asian countries have successfully done.

Source: Forbes